Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation

Data collection methods

Secondary use of data
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

ZOLPIDEM
Population studied

Short description of the study population

All patients receiving a prescription of zolpidem recorded in the IMS Disease Analyser

Age groups

Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
Children (2 to < 12 years)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

18000000
Study design details

Main study objective

the prevalence of zolpidem use in 2012 stratified by gender, age, strength and prescribed daily dose. In addition new users in 2011 has been characterised and the percentage and these new users are followed up after 3-6 months

Outcomes

Prevalence of prescribing in 2012-Stratified on age and gender-Stratified on prescribed strength-Stratified on the prescribed daily doseIncident use in 2011-stratified as above-Percentage having prescribed zolpidem 3-6 months after the initial prescription

Data analysis plan

Descriptive study design. New user have been defined as patients with no prescription of the drug in question in the previous 12 months before first prescription in the calendar year in question (2011).Age grouping done to isolate elderly aged 65-79 and the very old aged 80 and older. The drug in question will be well captured in primary care databases (internal validity good) and the databases are considered representative for their respective countries (external validity good).
Documents
Study results

zolpidem report final with annex

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